Clinical Trials /

Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

NCT00412594

Description:

This phase II trial studies the side effects and how well cladribine and rituximab work in treating patients with hairy cell leukemia. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cladribine together with rituximab may kill more cancer cells.

Related Conditions:
  • Hairy Cell Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 2CDA With Rituximab in Hairy Cell Leukemia
  • Official Title: Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed By Rituximab in Hairy Cell Leukemia

Clinical Trial IDs

  • ORG STUDY ID: 2004-0223
  • SECONDARY ID: NCI-2012-01394
  • NCT ID: NCT00412594

Conditions

  • Leukemia

Interventions

DrugSynonymsArms
CladribineLeustatin, 2-Cda2CDA + Rituximab
RituximabRituxan2CDA + Rituximab

Purpose

The goal of this clinical research study is to learn if treatment with 2CDA (cladribine) followed by treatment with rituximab can help to control HCL. The safety of this combination treatment will also be studied.

Detailed Description

      Cladribine is a chemotherapy drug that has been used for over 10 years to treat HCL with
      very good results and very low rate of side effects. Rituximab is an antibody protein that
      targets a specific molecule on the surface of cancer cells in order to eliminate them. It
      has been used for over 5 years to treat a number of cancers of blood and lymph nodes and has
      been used with some success to treat patients with HCL whose disease has returned after a
      previous remission.

      If you are found to be eligible to take part in this study, you will receive cladribine by
      vein over 2 hours once a day for 5 days in a row. You will only receive 1 cycle (5 days) of
      this treatment. Then you will receive rituximab by vein once a week for 8 weeks. Treatment
      with rituximab will start around Day 28.

      After the first dose of each study drug has been given to you at MD Anderson, all later
      doses of both drugs can be given to you by your community doctor in your home town. You will
      have a weekly blood tests (about 1 teaspoon each) for the first 4 weeks and before receiving
      rituximab. You will have a repeat bone marrow biopsy before starting rituximab in order to
      see how much disease is left behind. You will then have a blood test (about 1 teaspoon)
      every 2 to 4 weeks while you are receiving rituximab. A bone marrow biopsy will also be done
      at the end of rituximab treatment.

      You will be taken off the study if the disease gets worse or if intolerable side effects
      occur. After completing rituximab, you will return for a follow-up visit every 3 months for
      one year. At these visits you will have blood (about 1 teaspoon) tests performed.

      This is an investigational study. Both drugs are approved by the FDA and are commercially
      available. Their use together in this study, however, is experimental. A total of 150
      patients will take part in this study. All will be enrolled at MD Anderson.
    

Trial Arms

NameTypeDescriptionInterventions
2CDA + RituximabExperimentalCladribine (2CDA) 5.6 mg/m^2 by vein over 2 hours daily for 5 days; Rituximab 375 mg/m^2 by vein weekly times 8 starting on day 28 (plus or minus 4 days) following 2CDA treatment.
  • Cladribine
  • Rituximab

Eligibility Criteria

        Inclusion Criteria:

          1. Age 18 years and older

          2. Diagnosis of HCL established by bone marrow examination

          3. Patients with relapsed disease are eligible if they have had no more than one prior
             therapy

          4. Women of child-bearing potential must use birth control (oral contraceptive, barrier,
             abstinence or any other acceptable method) for the duration of the study

          5. Performance status </= 3

          6. Adequate renal function: creatinine less than or equal to 2.0 unless related to the
             disease

          7. Adequate liver function: bilirubin less than or equal to 3.0, transaminases less than
             or equal 3 x upper limit of normal unless related to the disease

          8. No prior investigational agent in the 4 weeks prior to initiation of therapy

        Exclusion Criteria:

          1. Unable or unwilling to sign the consent form

          2. Known infection with HIV, hepatitis B or C

          3. Presence of active infection

          4. Presence of CNS metastases

          5. New York Heart Association Classification III or IV heart disease (See Appendix I)

          6. Prior chemotherapy (last 4 weeks)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Complete Response
Time Frame:12 weeks
Safety Issue:
Description:Complete response (CR) defined as absence of hairy cells in the bone marrow (BM) or presence of less than 1% atypical cells (not definitively called hairy cells) and disappearance of all evidence of HCL on physical examination. Hematologic parameters for CR require an ANC of 1.5 x 109/L or greater; Hgb at least 12.0 g/dL (at least 11.0 g/dL for females); and PLT at least 100 x 109/L without growth factor or transfusion support. CR with residual disease (CR-RD) is defined as for CR but with persistence of 1% to 5% hairy cells in the marrow (but no circulating hairy cells).

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:M.D. Anderson Cancer Center

Trial Keywords

  • Hairy Cell Leukemia
  • Leukemia
  • 2CDA
  • 2-chlorodeoxyadenosine
  • Rituximab
  • Rituxan
  • HCL

Last Updated

January 24, 2017